Administrative data

Description of key information

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is 2050 mg/kg bw in rats.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue fenchol, The acute dermal LD50 value of the test item was >2000 mg/kg bw in guinea pigs.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route.

The acute oral LD50 value of the test substance was found to be 2050 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw.

REPORTING FORMAT FOR THE ANALOGUE APPROACHThe analogue substance fenchol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 050 mg/kg bw

Based on:

other: Read across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 = 2050 mg/kg bw

Mortality:

All deaths occurred between days 1 and 3.At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw.

Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is expected to be 2050 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 mg/kg bw in rats.

REPORTING FORMAT FOR THE ANALOGUE APPROACH The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 7 859 mg/kg bw

Based on:

other: Read-across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 > 10000 mg/kg bw.

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.

Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol was determined to be >7859 mg/kg bw in rats.

REPORTING FORMAT FOR THE ANALOGUE APPROACH The analogue substance L-Borneol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

6 500 mg/kg bw

Based on:

other: Read-across from an analogue

Remarks on result:

other: read-across from an analogue for which LC50 = 6500 mg/L

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.

Executive summary:

Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.

REPORTING FORMAT FOR THE ANALOGUE APPROACH The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

7 072 mg/kg bw

Based on:

other: Read-across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 = 9000 mg/kg bw

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.

Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol was determined to be 7072 mg/kg bw in mice.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

2 050 mg/kg bw

Quality of whole database:

Weight of evidence from several peer reviewed articles and secondary literature.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVINGAccording to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route.

The acute dermal LD50 value of the test substance was >2000 mg/kg bw in guinea pigs.

Executive summary:

The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw.

REPORTING FORMAT FOR THE ANALOGUE APPROACHThe analogue substance fenchol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: Read across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 > 2000 mg/kg bw

Mortality:

No deaths ocurred.

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue fenchol, the acute dermal LD50 value of the d-alpha fenchol is expected to be >2000 mg/kg bw in guinea pigs.

Executive summary:

The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.

REPORTING FORMAT FOR THE ANALOGUE APPROACH The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 15 717 mg/kg bw

Based on:

other: Read-across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 > 20000 mg/kg bw.

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item is >15717 mg/kg bw in rabbits.

Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.

REPORTING FORMAT FOR THE ANALOGUE APPROACH The analogue substance L-Borneol which shares the same functional groups with the substance D-alpha fenchol also has comparable values for the relevant molecular properties.See attached the reporting format.

Reason / purpose:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: Read-across from an analogue

Remarks on result:

other: read-across from an analogue for which LD50 > 2000 mg/kg bw.

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.

Executive summary:

Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

2 000 mg/kg bw

Quality of whole database:

Weight of evidence from several peer reviewed articles and secondary literature.

Additional information

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.

Acute oral toxicity: Weight of evidence: The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 mg/kg bw in rats.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. The acute dermal toxicity of the test item was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route.

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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